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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00989976 |
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Date of registration:
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01/10/2009 |
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Primary sponsor: |
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Public title:
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Individual Differences in Diabetes Risk: Role of Sleep Disturbances
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Scientific title:
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Individual Differences in Diabetes Risk: Role of Sleep Disturbances |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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32 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00989976 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Florian Chapotot, PhD |
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Address:
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Telephone:
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773-834-3437 |
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Email:
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fchapotot@uchicago.edu |
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Affiliation:
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Name:
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Florian Chapotot, PhD |
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Address:
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Telephone:
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Email:
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fchapotot@uchicago.edu |
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Affiliation:
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Name:
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Eve Van Cauter, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the
gender distribution in each group matching the gender distribution of active duty
Army personnel (85% men; 15% women) based on the following inclusion criteria:
- age 18 to 29 years,
- normal weight or modestly overweight (BMI = 27 kg/m2 for women, BMI = 28 kg/m2
for men),
- normal findings on clinical examination, normal routine laboratory tests
results, normal EKG, no history of psychiatric, endocrine, cardiac or sleep
disorders.
- Only subjects who have regular life styles (no shift work, no travel across time zone
during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take
medications will be recruited.
- An overnight polysomnography will be performed to rule out sleep-disordered breathing
(apnea-hypopnea index > 5/hour) and periodic limb movement disorder (PLM arousal
index >1/hour).
- Women taking hormonal contraceptive therapy and pregnant women will be excluded. In
women, all studies will be initiated in the early follicular phase.
Exclusion Criteria:
- Tobacco use.
- Habitual alcohol use of more than 2 1 drink per day.
- Excessive caffeine intake of more than 300 mg per day and individuals with a metal
implant or another metal object in their body.
We estimate that we will need to recruit at least 60-70 individuals to obtain two
gender-matched groups of 16 individuals with either low or high SWA.
Age minimum:
18 Years
Age maximum:
29 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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Sleep
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Intervention(s)
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Behavioral: bedtime restriction
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Behavioral: normal sleep times
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Primary Outcome(s)
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diabetes risk as assessed by disposition index
[Time Frame: Dec. 2011]
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Secondary ID(s)
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#16028A
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DOD PR064727
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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